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Opternative working with FDA on medical device clearance

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Opternative announced it is working with the FDA to comply with regulatory requirements.

The FDA posted a warning letter in early March that it issued to Opternative in October 2017 stating that the company is marketing the On-Line Opternative Eye Examination Mobile Medical App device in the U.S. without marketing clearance or approval, in violation of the Federal Food, Drug and Cosmetic Act.

Opternative stated in a press release that it has been working closely with the FDA since the early days of the company, it responded promptly to the FDA warning letter and is “working diligently” to voluntarily comply with all regulatory requirements.

The company said in the release that it was founded on the premise that consumers need increased access to vision exams, and remote vision tests can contribute to solving that need.

The company said it continues to communicate with the FDA on a regular basis to work through the regulatory medical device clearance process with Opternative’s outside experts.